The present invention relates generally to systems for placing and securing a nasal tube; and more particularly to such a system which utilizes magnets in the placement of a bridle used in combination with a receiver to secure the nasal tube.
Many different methods have been used to place nasal tubes, such as feeding tubes, nasogastric tubes, and nasotracheal tubes into patients and to secure the tubes once placed. One such method disclosed in U.S. Pat. No. 5,185,005 to Ballantyne requires a bridle which is pulled into a nare of a patient""s nose, around the posterior nasal septum, and out the other nare by a cord attached to the bridle and an insertion tool. Specifically, first and second installation tools are inserted into the nares of the patient""s nose. Magnets associated with each tool couple together behind the posterior nasal septum. In the preferred embodiment, the pulling cord is attached to a magnetic assembly which is pulled free of its insertion tool by the removal of the remaining insertion tool. In this manner, removal of the second insertion tool pulls the bridle via the pulling cord through the first insertion tool and into a nare of the patient""s nose, behind the nasal septum, and out of the other nare.
In an alternate embodiment described in the ""005 patent, the bridle itself is associated with the magnet utilizing a fastening plate which is drilled and countersunk. The bridle is inserted through the drilled hole and knotted. The knot rests in the countersunk cavity of the fastening plate which is magnetically coupled to the magnet. Although the utilization of magnets to loop a bridle behind the nasal septum of a patient represents an advancement in the art, the apparatus described in the ""005 patent includes numerous parts which are difficult to manufacture and time consuming to assemble. These difficulties increase the per unit cost of the apparatus and the opportunities for defects.
Prior to the ""005 patent, U.S. Pat. No. 4,778,448 to Meer represented the state of the art. The ""448 patent requires ends of a bridle to be inserted into first and second nares of a patient""s nose until the ends are visible in the posterior pharynx of the patient. The visible ends of the bridle are then pulled out of the mouth of the patient using forceps or the like. The ends are then secured together forming a loop. The end of the loop adjacent the posterior nasal septum is then pulled such that the end of the loop protruding through the mouth is pulled back into the mouth, up the posterior pharynx and out of one of the nostrils. The harness is subsequently cut to a desired size such that the exterior end of the loop is adjacent the posterior nasal septum and rejoined. Although effective, the placement of the harness in this manner is both time consuming and difficult to undertake. Further, the process of placing the harness is uncomfortable for the patient and carries the risk of dislocation of the mandible since the patient""s jaw must be opened widely to identify the ends of the harness in the posterior pharynx.
Additional methods for securing nasal tubes include attaching the tubes directly to the skin of the recipient utilizing an adhesive such as tape or the like, as described for example in U.S. Pat. Nos. 4,114,626 and 4,282,871, or sutures. All of these methods which rely on an adhesive to secure the feeding tubes have in common the disadvantages of being uncomfortable for the patient, gradually losing adhesion over time, risking injury to the underlying skin, or causing pressure necrosis of the nose itself from holding the tube tightly opposed to the nose.
Thus, as demonstrated by the limitations and disadvantages of the prior art methods for placing and securing nasal tubes in patients, there is a need identified for an improved bridle system and related method for placing and securing nasal tubes which allows rapid, easy looping of a bridle around the posterior nasal septum with minimal patient discomfort and no risk of mandibular dislocation. A need also exists for tools utilized to place the bridle which are few in number and simple to manufacture thus lowering the per unit cost of the bridle system such that the system may be pre-packaged and disposable. An additional need exists for a universal system capable of use with any type and/or size of nasal tube in order to limit the amount of storage space required in the medical facility.
The present invention meets these needs by providing an improved system for placing and securing at least one nasal tube in a patient comprising a flexible member having a first end portion for insertion into a first nare of a patient""s nose and a second end portion, a first magnet secured substantially within the first end portion, a magnetic probe for insertion into a second nare of the nose for attracting the first magnet and retrieving the flexible member through the second nare, and a receiver for securing the tube and the flexible member once placed.
In accordance with a first aspect of the present invention, the receiver includes first and second pivotally connected portions forming a main body. A first channel having an opening along an axial direction thereof is formed in a first portion of the main body. At least portions of the channel opening, and preferably all of the opening, are smaller than an outer diameter of the tube for receiving and securing, or snapping, the tube into place. Additional channels may be formed in one or both portions of the main body for receiving the end portions of the flexible member.
In accordance with a second aspect of the present invention, an axis of the first channel may be offset from a line drawn through axes of the additional channels in order to minimize the size of the receiver. In addition, the receiver may be selected from a group of integrally molded receivers having first channels of different radii which allows the system to be utilized with any type and/or size nasal tube. Additional channels or recesses may be formed along exterior surfaces of one or both main body portions of the receiver for partially receiving the first, or additional nasal tubes, if desired. A fastener may also be provided for securing the tubes against the exterior surfaces of the receiver which are preferably smooth or contoured to prevent irritation of the patient""s skin.
In accordance with another aspect of the present invention, the flexible member may be tubular and capable of receiving a rod or stylus inserted into a lumen thereof to provide additional rigidity during its insertion. Depending upon the initial rigidity of the flexible member, the rigidity of the stylus may vary and the stylus may even be unnecessary. In addition, the flexible member and/or the magnetic probe may include at least one indicia thereon indicating at least one insertion distance. The distance indicated by the indicia is preferably equal to an average distance from the nares to just beyond the choanal aperture.
According to yet another aspect of the present invention, a disposable kit for placing and securing a tube in a patient comprises a flexible member having first and second ends for insertion into a first nare of the patient""s nose, a magnet attached to the first end of the flexible member, a magnetic probe for insertion into a second nare of the nose to attract the magnet and retrieve the magnet and the flexible member, and a group of integrally molded receivers for securing different types and/or sizes of tubes and the flexible member. Advantageously, the kit is self-contained with each of its component parts sterilized before placement therein.
In accordance with still another aspect of the present invention, a method for placing and securing a tube through a nose into a patient is provided. The method includes the steps of inserting at least one tube into a first or a second nare of the nose, inserting an end portion of a flexible member having a magnet substantially secured therein into the first nare of the nose, inserting a magnetic probe into the second nare of the nose for attracting the magnet/flexible member, removing the magnetic probe from the second nare of the nose thereby retrieving the end portion of the flexible member through the second nare of the nose, and securing the at least one tube and the flexible member. The step of securing the at least one tube may include the step of snapping the tube into a channel of a receiver. The method may further comprise the step of selectively removing the receiver from a group of integrally molded receivers for use in the securing step. The unselected receivers which may include spare receivers and/or receivers for use with different size tubes may be discarded.
Additional advantages, and other novel features of the invention will be set forth in part in the description that follows and in part will become apparent to those skilled in the art upon examination of the following or may be learned with the practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.